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NCT05765838 Clinical Trial

Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.

COVID-19 Clinical Trial

Official title:
Combined Molecular Testing for Influenza, SARS-CoV-2, and RSV RNA From Different Upper Airway Specimens.

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05765838
Other study ID # H-23006949
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 3, 2023
Est. completion date July 1, 2023

Study information
Verified date March 2023
Source Rigshospitalet, Denmark
Contact Tobias Todsen, MD
Phone +35453545
Email tobias.todsen@regionh.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a comparative prospective diagnostic accuracy study reported according to the STARD guidelines. Citizens at an outpatient COVID19 test facility at Testcenter Danmark Valby will be invited to participate in the study on a volunteer basis. The enrolled participants will have the planned oropharyngeal swab performed in the test center and sent for a SARS-CoV-2 RT-PCR test at TestCenter Danmark, Statens Serum Institut, Copenhagen, Denmark as usual. Besides the planned oropharyngeal swab performed in the test center, the participants will have additional specimens collected in form of saliva, nasopharyngeal-, nasal-, and oropharyngeal swabs. These will all be used for the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B. Further we will measure immune mediating cytokines, chemokines, and interleukins in the different specimens. These analyses will be performed at Technical University of Denmark (DTU).

Recruitment information / eligibility
Status Recruiting
Enrollment 250
Est. completion date July 1, 2023
Est. primary completion date April 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility The inclusion criterion: A. 18 years or more of age requiring a test for COVID-19. The exclusion criteria are : A. Neck breathers (tracheostomy/laryngectomy patients) or other nasopharyngeal or oropharyngeal anomalies that do not allow for sampling using swabs. B. Do not understand oral or written Danish

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• (NPS right - Nasal swab left - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (NPS left - Nasal swab right - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (Nasal swab right - NPS left - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (Nasal swab left - NPS right - OPS)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (NPS right - OPS - Nasal swab left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (NPS left - OPS - Nasal swab right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (Nasal swab right - OPS - NPS left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (Nasal swab left - OPS - NPS right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (OPS - NPS right - Nasal swab left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (OPS - NPS left - Nasal swab right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (OPS - Nasal swab left - NPS right)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order
• (OPS - Nasal swab right - NPS left)
Collection of nasopharyngeal-, nasal-, and oropharyngeal swabs in randomized order

Locations
Country Name City State
Denmark Valby COVID19 testcenter Copenhagen

Sponsors (1)
Lead Sponsor Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary RT-PCR for upper airway viral diagnostics the detection of nucleic acids from the four most common strains of influenza (B Yamagata, B Victoria, A H1N1 and A H3N2), SARS-CoV-2 and RSV A/B 1 day
Secondary local immunological mediators from the upper airway tract measure interferon ? (IFN-?), C-X-C motif chemokine 10 (CXCL10/IP10), interleukin 10 (IL-10), interleukin 12p70, interleukin 13 (IL-13), interleukin 1ß (IL-1ß), interleukin 2, interleukin 4 (IL-4), interleukin 5 (IL-5), interleukin 6, CXCL8, tumor necrosis factor a (TNF-a), C-C motif chemokine 5 (CCL5/RANTES), interferon a2a, and granulocyte macrophage colony-stimulating factor (GM-CSF). 1 day
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